16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
FDA 510(k)
FDA Class 2
·Immunology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074033228·BONE SCREW 7042735 20 DEG ILC 7.5X35 TI
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868210·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
5-Lead Leadset,Adt/Ped,AHA,Snap
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004570·
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664884686·ECG Monitor Lead wire/MR style/5-lead/Snap/AHA/...
CLEARFIL DC CEMENT
FDA 510(k)
FDA Class 2
·Dental
ASCENT XXL OPEN BOX FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 4, 2024
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
VITALITY 2 VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ADVIA CENTAUR XP
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 6, 2011
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 6, 2022
UNK HIP ACETABULAR CUP PINNACLE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 6, 2022
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 6, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024